Back to resultsEfficacy of 5 Weeks of Treatment With BGG492 in Patients With Spasticity Due to Multiple Sclerosis
Primary Purpose
Muscle Spasticity Due to Multiple Sclerosis
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
BGG492
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Muscle Spasticity Due to Multiple Sclerosis focused on measuring Spasticity, Multiple Sclerosis
Eligibility Criteria
Key Inclusion Criteria:
- Diagnosis of multiple sclerosis (MS) of any type.
- MS diagnosis at least 6 months prior to screening.
- Stable MS with no relapse within 3 months prior to screening.
- Treated or untreated spasticity due to MS for at least 3 months prior to screening, not wholly relieved with antispasticity medications.
Key exclusion criteria:
- Patients with symptoms of spasticity not due to MS.
- Patients taking three or more different anti-spasticity medications.
- Acute MS exacerbation requiring treatment within 3 months of the Screening Visit.
- Initiation of, or the discontinuation of interferon beta or any other disease modifying therapy for MS within 3 months of the Screening Visit.
- Use of baclofen pump at any time.
- Wheelchair or bed-bound patients.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
BGG492
Placebo
Arm Description
BGG492 tablets administered orally
Matching placebo administered orally
Outcomes
Primary Outcome Measures
Change in spasticity NRS score from baseline to 5 weeks
The spasticity Numeric Rating Scale is a 0 to 10 patient reported scale of spasticity severity, with 0 being no spasticity and 10 being worst possible spasticity.
PGIC score at 5 weeks
The Patient Global Impression of Change is a patient reported one item mesaure of overall improvement in condition since the previous visit. The patient is asked to choose one of 7 sentences from very much improved to very much worse, that best describes his present condition.
Secondary Outcome Measures
Change from baseline to 5 weeks in Ashworth spasticity score
The Ashworth spasticity score is a physician assessed rating of spasticity using a five point score from 0 to 4 for each muscle group tested.
Safety and tolerability
Number of patients with adverse events (AE).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01649050
Brief Title
Efficacy of 5 Weeks of Treatment With BGG492 in Patients With Spasticity Due to Multiple Sclerosis
Official Title
A Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel-group Study to Assess the Efficacy of 5 Weeks of Treatment With BGG492 in Patients With Spasticity Due to Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Withdrawn
Study Start Date
October 2016 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
March 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate efficacy and safety of BGG492 versus placebo on moderate to severe spasticity due to multiple sclerosis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Spasticity Due to Multiple Sclerosis
Keywords
Spasticity, Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BGG492
Arm Type
Experimental
Arm Description
BGG492 tablets administered orally
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo administered orally
Intervention Type
Drug
Intervention Name(s)
BGG492
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in spasticity NRS score from baseline to 5 weeks
Description
The spasticity Numeric Rating Scale is a 0 to 10 patient reported scale of spasticity severity, with 0 being no spasticity and 10 being worst possible spasticity.
Time Frame
5 weeks
Title
PGIC score at 5 weeks
Description
The Patient Global Impression of Change is a patient reported one item mesaure of overall improvement in condition since the previous visit. The patient is asked to choose one of 7 sentences from very much improved to very much worse, that best describes his present condition.
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Change from baseline to 5 weeks in Ashworth spasticity score
Description
The Ashworth spasticity score is a physician assessed rating of spasticity using a five point score from 0 to 4 for each muscle group tested.
Time Frame
5 weeks
Title
Safety and tolerability
Description
Number of patients with adverse events (AE).
Time Frame
average of 70 days, maximum from day -19 to day 52, i.e. from first baseline up to study completion visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Diagnosis of multiple sclerosis (MS) of any type.
MS diagnosis at least 6 months prior to screening.
Stable MS with no relapse within 3 months prior to screening.
Treated or untreated spasticity due to MS for at least 3 months prior to screening, not wholly relieved with antispasticity medications.
Key exclusion criteria:
Patients with symptoms of spasticity not due to MS.
Patients taking three or more different anti-spasticity medications.
Acute MS exacerbation requiring treatment within 3 months of the Screening Visit.
Initiation of, or the discontinuation of interferon beta or any other disease modifying therapy for MS within 3 months of the Screening Visit.
Use of baclofen pump at any time.
Wheelchair or bed-bound patients.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Efficacy of 5 Weeks of Treatment With BGG492 in Patients With Spasticity Due to Multiple Sclerosis
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